Events

Recall of Device Recall LifeStyles Assorted Colors with Spermicide

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Ansell Healthcare Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    25095
  • Event Risk Class
    Class 2
  • Event Number
    Z-0402-03
  • Event Initiated Date
    2002-11-25
  • Event Date Posted
    2002-12-31
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2003-10-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=25148
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Condom With Nonoxynol-9 - Product Code LTZ
  • Reason
    The condoms are being recalled because information recently available indicates some of these condoms do not meet airburst test standards.
  • Action
    Recall letters dated 11/25/02 were issued to direct accounts via U.S. Mail, asking wholesalers to stop distribution of the lot, return stocks on hand, and conduct a recall to the retail level.

Device

Device Recall LifeStyles Assorted Colors with Spermicide
  • Model / Serial
    ANSELL HEALTHCARE INC.    LOT NUMBER PRODUCT CODE DESCRIPTION  0912C01622 6000 LS ASST CLRS W/SPL STPS 1000''S 0912C01522 6000 LS ASST CLRS W/SPL STPS 1000''S 0912C01422 6000 LS ASST CLRS W/SPL STPS 1000''S 0912C01322 6000 LS ASST CLRS W/SPL STPS 1000''S 0912C01222 6000 LS ASST CLRS W/SPL STPS 1000''S 0912C01122 6000 LS ASST CLRS W/SPL STPS 1000''S 0911C00322 6000 LS ASST CLRS W/SPL STPS 1000''S 0911C00222 6000 LS ASST CLRS W/SPL STPS 1000''S 0911C00122 6000 LS ASST CLRS W/SPL STPS 1000''S 0910C02222 6000 LS ASST CLRS W/SPL STPS 1000''S 0910C02122 6000 LS ASST CLRS W/SPL STPS 1000''S 0910C02022 6000 LS ASST CLRS W/SPL STPS 1000''S 0910C01922 6000 LS ASST CLRS W/SPL STPS 1000''S 0910C01822 6000 LS ASST CLRS W/SPL STPS 1000''S 0910C01722 6000 LS ASST CLRS W/SPL STPS 1000''S 0910C01622 6000 LS ASST CLRS W/SPL STPS 1000''S 0910C01522 6000 LS ASST CLRS W/SPL STPS 1000''S 0910C01422 6000 LS ASST CLRS W/SPL STPS 1000''S 0909C02722 6000 LS ASST CLRS W/SPL STPS 1000''S 0909C02522 6000 LS ASST CLRS W/SPL STPS 1000''S 0909C00722 6000 LS ASST CLRS W/SPL STPS 1000''S 0909C00622 6000 LS ASST CLRS W/SPL STPS 1000''S 0909C00522 6000 LS ASST CLRS W/SPL STPS 1000''S 0909C00422 6000 LS ASST CLRS W/SPL STPS 1000''S 0909C00322 6000 LS ASST CLRS W/SPL STPS 1000''S 0909C00222 6000 LS ASST CLRS W/SPL STPS 1000''S 0908C04822 6000 LS ASST CLRS W/SPL STPS 1000''S 0908C04722 6000 LS ASST CLRS W/SPL STPS 1000''S 0908C04622 6000 LS ASST CLRS W/SPL STPS 1000''S 0908C04522 6000 LS ASST CLRS W/SPL STPS 1000''S 0908C04422 6000 LS ASST CLRS W/SPL STPS 1000''S 0908C04322 6000 LS ASST CLRS W/SPL STPS 1000''S 0908C04222 6000 LS ASST CLRS W/SPL STPS 1000''S 0908C04122 6000 LS ASST CLRS W/SPL STPS 1000''S 0908C04022 6000 LS ASST CLRS W/SPL STPS 1000''S 0908C03922 6000 LS ASST CLRS W/SPL STPS 1000''S 0908C03822 6000 LS ASST CLRS W/SPL STPS 1000''S 0908C03722 6000 LS ASST CLRS W/SPL STPS 1000''S 0908C03622 6000 LS ASST CLRS W/SPL STPS 1000''S 0908C03522 6000 LS ASST CLRS W/SPL STPS 1000''S 0908C03422 6000 LS ASST CLRS W/SPL STPS 1000''S 0908C03322 6000 LS ASST CLRS W/SPL STPS 1000''S 0908C03222 6000 LS ASST CLRS W/SPL STPS 1000''S 0908C03022 6000 LS ASST CLRS W/SPL STPS 1000''S 0908C02922 6000 LS ASST CLRS W/SPL STPS 1000''S 0908C02822 6000 LS ASST CLRS W/SPL STPS 1000''S 0908C02722 6000 LS ASST CLRS W/SPL STPS 1000''S 0908C02622 6000 LS ASST CLRS W/SPL STPS 1000''S 0908C02522 6000 LS ASST CLRS W/SPL STPS 1000''S 0908C02422 6000 LS ASST CLRS W/SPL STPS 1000''S 0908C02322 6000 LS ASST CLRS W/SPL STPS 1000''S 0908C02222 6000 LS ASST CLRS W/SPL STPS 1000''S  0001990122 6000 LS ASST CLRS W/SPL STPS 1000''S 0001990222 6000 LS ASST CLRS W/SPL STPS 1000''S 0001990322 6000 LS ASST CLRS W/SPL STPS 1000''S 0001990422 6000 LS ASST CLRS W/SPL STPS 1000''S 0001990822 6000 LS ASST CLRS W/SPL STPS 1000''S 0001990922 6000 LS ASST CLRS W/SPL STPS 1000''S 0001991622 6000 LS ASST CLRS W/SPL STPS 1000''S 0001991922 6000 LS ASST CLRS W/SPL STPS 1000''S 0001992122 6000 LS ASST CLRS W/SPL STPS 1000''S 0002990422 6000 LS ASST CLRS W/SPL STPS 1000''S 0002990522 6000 LS ASST CLRS W/SPL STPS 1000''S 0004990122 6000 LS ASST CLRS W/SPL STPS 1000''S 0004990222 6000 LS ASST CLRS W/SPL STPS 1000''S 0004990322 6000 LS ASST CLRS W/SPL STPS 1000''S 0004990422 6000 LS ASST CLRS W/SPL STPS 1000''S 0004990522 6000 LS ASST CLRS W/SPL STPS 1000''S 0004990622 6000 LS ASST CLRS W/SPL STPS 1000''S 0004990722 6000 LS ASST CLRS W/SPL STPS 1000''S 0004990822 6000 LS ASST CLRS W/SPL STPS 1000''S 0004990922 6000 LS ASST CLRS W/SPL STPS 1000''S 0005990122 6000 LS ASST CLRS W/SPL STPS 1000''S 0005990222 6000 LS ASST CLRS W/SPL STPS 1000''S 0005990322 6000 LS ASST CLRS W/SPL STPS 1000''S 0005990422 6000 LS ASST CLRS W/SPL STPS 1000''S 0005990522 6000 LS ASST CLRS W/SPL STPS 1000''S 0005990622 6000 LS ASST CLRS W/SPL STPS 1000''S 0005990722 6000 LS ASST CLRS W/SPL STPS 1000''S 0005990822 6000 LS ASST CLRS W/SPL STPS 1000''S 0005990922 6000 LS ASST CLRS W/SPL STPS 1000''S 0005991022 6000 LS ASST CLRS W/SPL STPS 1000''S 0006991222 6000 LS ASST CLRS W/SPL STPS 1000''S 0007991022 6000 LS ASST CLRS W/SPL STPS 1000''S 0007991122 6000 LS ASST CLRS W/SPL STPS 1000''S 0007991222 6000 LS ASST CLRS W/SPL STPS 1000''S 0007991322 6000 LS ASST CLRS W/SPL STPS 1000''S 0007991422 6000 LS ASST CLRS W/SPL STPS 1000''S 0007991522 6000 LS ASST CLRS W/SPL STPS 1000''S 0007991622 6000 LS ASST CLRS W/SPL STPS 1000''S 0007991722 6000 LS ASST CLRS W/SPL STPS 1000''S 0008990622 6003 LS ASST COLORS W/SPL FP 3''S 0008990922 6000 LS ASST CLRS W/SPL STPS 1000''S 0008991022 6000 LS ASST CLRS W/SPL STPS 1000''S 0008991122 6000 LS ASST CLRS W/SPL STPS 1000''S 0008991222 6000 LS ASST CLRS W/SPL STPS 1000''S 0008992022 6000 LS ASST CLRS W/SPL STPS 1000''S 0009991322 6003 LS ASST COLORS W/SPL FP 3''S 0009992122 6003 LS ASST COLORS W/SPL FP 3''S 0009992222 6003 LS ASST COLORS W/SPL FP 3''S 0106992622 6000 LS ASST CLRS W/SPL STPS 1000''S 0106992722 6000 LS ASST CLRS W/SPL STPS 1000''S
  • Product Classification
    Obstetrical and Gynecological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide and Europe
  • Product Description
    LifeStyles Assorted Colors Condoms with Spermicide
  • Manufacturer
    Ansell Healthcare Inc

Manufacturer

Ansell Healthcare Inc
  • Manufacturer Address
    Ansell Healthcare Inc, 1500 Industrial Road, Dothan AL 36303
  • Source
    USFDA